Abstract

DESIGN, PREPARATION, EVALUATION, COMPATIBILITY AND INVITRO STUDIES OF NAPROXEN AND ESOMEPRAZOLE MULTILAYER TABLETS: LAYER BY LAYER TABLET TECHNOLOGY

Irin Dewan*, Sadiya Afrose Jahan, Mahjabeen Gazi, Joydeb Nath, Md. Asaduzzaman, Maksud Al- Hasan

Abstract

The rationale of the present study was to design and prepare a combination product of naproxen and esomeprazole tablet by layer by layer tableting method. In this method shellac, cellulose acetate phthalate, methacrylic acid (copolymers), polyvinyl acetate phthalate and hypromellose phthalate were used as an enteric coating agent, to provide delayed action of naproxen, and esomeprazole was combined as an immediate release part which was added as a drug layer around the enteric coated naproxen core through a coating suspension. The granules and finished tablet were evaluated for their flow properties, diameters, thickness, hardness, friability and disintegration time. The selected core tablet was then sub coated with five different sub coating materials (E1-E5) in different concentrations (8%, 10% and 12%). Finally the product was completed with a finishing touch of coating layer with a coloring agent and polishing powder to provide a protection of esomeprazole layer and to improve the asthetic value of the product. The tablets were analyzed at several stages during development. FTIR studies revealed that there was no interaction between the drug and excipients used in the study. Core and enteric coating the delayed release profile was checked using USP II type dissolution apparatus in different media. The release mechanisms of naproxen enteric coated tablets were explored and explained with Zero order, first order, Higuchi, Korsmeyer and Hixon Crowell equations. The in–vitro release data were fitted with several mathematical models and mean dissolution time along with fractional dissolution time values (T25%, T50% and T80%) were calculated. The final results indicate a complete combination of naproxen and esomeprazole and with good analytical results.

Keywords: Layer by layer technology, Naproxen, Esomeprazole.